Impact of the Mandibular Advancement Device on Sleep Apnea Syndrome During Discontinuation of Treatment With Continuous Positive Airway Pressure: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in subjective sleepiness
研究概览
简要总结
Obstructive sleep apnea hypopnea syndrome (OSAS) is a frequent disease with neuropsychological and cardiovascular (CV) consequences. Continuous positive pressure (CPAP), the main treatment for OSAHS, is effective on the majority of symptoms but restrictive, which can promote non-compliance. Treatment interruptions are often observed in connection with intercurrent events such as nasal obstructions or even when patients are on the move. However, randomized trials have shown that stopping treatment, even for a short time, leads to a recurrence of symptoms and significant CV disturbances (increase in blood pressure, endothelial dysfunction, cardiac repolarization disorders). It seems important to consider strategies that promote therapeutic continuity. The mandibular advancement device (MAD) is an interesting tool in this regard. MAD is as effective as CPAP on symptoms and CV data. The investigators want to assess its effectiveness as a complementary treatment during treatment discontinuation on the main consequences of OSAHS.
详细描述
Patients are recruited during sleep consultations in the Angers University Hospital pneumology department among patients followed for severe OSAHS and treated with CPAP. All of the scheduled examinations are carried out in the sleep laboratory of the CHU d'Angers.
Patients meeting the inclusion criteria and not having any non-inclusion criteria are randomized to the "MAD" group or to the "control" group. For patients in the "MAD" group, an appointment with a stomatologist is organized to make and adjust a thermo-molded type MAD.
An initial assessment is carried out for all patients during a day hospitalization specific to the study (study of endothelial function, blood pressure, Osler test, ECG, venous and urinary sampling, and completion of the study questionnaires).
Patients are then asked to stop CPAP treatment for two weeks. Patients in the OAM group use OAM during this period. Patients in the control group do not receive any specific treatment for their OSAHS during this period.
After 2 weeks of stopping CPAP, a second assessment, identical to the initial assessment, is carried out for all patients. This assessment is carried out during one night of hospitalization which also allows a PSG to be carried out under OAM or without treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient accepting MAD treatment
- •Patient with an apnea-hypopnea index (AHI) greater than 15 events per hour on the initial recording
- •Patient with excessive daytime sleepiness during initial treatment (ESE>10)
- •Patient treated for more than 12 months by CPAP with average compliance greater than 5 hours per night
排除标准
- •Initial severe daytime sleepiness characterized
- •OSAS with ≥ 5 central apneas per hour of sleep at baseline recording
- •Previously diagnosed severe cardiac and/or respiratory pathology:
- •Body mass index ≥ 35 kg/m2
- •Known contraindication to OAM treatment
研究组 & 干预措施
control group
Patients will be ask not to use any OSAS treatment during the 2 weeks of the study (after the CPAP withdrawal)
mandibular advancement device
Patients will be asked to use mandibular advancement device during the 2 weeks CPAP withdrawal
干预措施: Mandibular advancement device treatment (Device)
结局指标
主要结局
Change in subjective sleepiness
时间窗: before and two weeks after CPAP withdrawal
Sleepiness assessed using the Epworth Sleepiness Scale
次要结局
- Change in objective sleepiness(before and two weeks after CPAP withdrawal)
- Change in subjective sleep quality(before and two weeks after CPAP withdrawal)
- Change in endothelial function(before and two weeks after CPAP withdrawal)
- Change in glucose levels(before and two weeks after CPAP withdrawal)
- Change in Microparticles(before and two weeks after CPAP withdrawal)
- Change in inflammation(before and two weeks after CPAP withdrawal)
- Change in catecholamines levels(before and two weeks after CPAP withdrawal)
- Change in 24 hour blood pressure(before and two weeks after CPAP withdrawal)
- Change in executive function(before and two weeks after CPAP withdrawal)
- Change in cardiac repolarization(before and two weeks after CPAP withdrawal)
- Change in oxydative stress(before and two weeks after CPAP withdrawal)